510(k) Report

510(k) · Cleared

Cleared

Parapost Fiber White

K000311510(k) TraditionalCleared Mar 14, 200042-day reviewClass I21 CFR 872.3810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coltene/Whaledent, Inc. · ELR Post, Root Canal

Cleared on Mar 14, 2000 after a 42-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 14, 2000
Review
42 days
Class
Class I
Product code
ELR
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2001: 1 descendant cleared2006: 1 descendant cleared200020052010201520202025
  1. This deviceK000311 Parapost Fiber WhiteColtene/Whaledent, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK012354 Snowpost, SnowlightDanville Materials, Inc. · 2001
  3. Descendant · cites it directly · 1 of its ownK020431 FibiocoreEst. Anthogyr · 2002
  4. Descendant · 2 generations on · 0 of its ownK060075 Fiber-Metal PostForemost Dental, LLC · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K012354Snowpost, SnowlightDanville Materials, Inc. · 2001 · cites it directly2descendants
  • K020431FibiocoreEst. Anthogyr · 2002 · cites it directly1descendant
  • K060075Fiber-Metal PostForemost Dental, LLC · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000311Parapost Fiber WhiteColtene/Whaledent, Inc.2000—
+1K012354Snowpost, SnowlightDanville Materials, Inc.2001—
+1K020431FibiocoreEst. Anthogyr2002—
+2K060075Fiber-Metal PostForemost Dental, LLC2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200610
FIG. 1 — Lineage of K000311, 2000–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ELR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012354Snowpost, SnowlightDanville Materials, Inc.20012
K020431FibiocoreEst. Anthogyr20021

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012354 (Danville Materials, Inc., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All ELR devices

ELR Post, Root Canal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELR

FDA has decided no ELR device since 2007.

Median 510(k) review, days · ELR

Too few ELR 510(k)s in any year since 2007 to give a median.

Recalls per year · ELR

1in 2018

2009: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ELR

1in 2025

2007: 82008: 52009: 32010: 12011: 42012: 132013: 62014: 302015: 32016: 82017: 12018: 52019: 202020: 22021: 32022: 22024: 12025: 1
2007high 30 (2014) · low 0 (2023)2025

MAUDE reports naming product code ELR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—08
20080—05
20090—13
20100—01
20110—04
20120—013
20130—06
20140—030
20150—03
20160—08
20170—01
20180—15
20190—020
20200—02
20210—03
20220—02
20230—00
20240—01
20250—01
20260—0—

More from Coltene/Whaledent, Inc.

21 FDA decisions under this applicant name. See the company

  • K071632Perfect Tissue Contouring System IIColtene/Whaledent, Inc. · 2007
  • K051660Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization SystemColtene/Whaledent, Inc. · 2005
  • K040551Coltolux Led Curing LightColtene/Whaledent, Inc. · 2004
  • K033760One Coat SE BondColtene/Whaledent, Inc. · 2004
  • K031752Coltosol FColtene/Whaledent, Inc. · 2003

Recent decisions in ELR

The ELR category page

  • K060075Fiber-Metal PostForemost Dental, LLC · 2006
  • K042848FRC Postec PlusIvoclar Vivadent, Inc. · 2004
  • K030820Everstick PostStick Tech, Ltd. · 2003
  • K020431FibiocoreEst. Anthogyr · 2002
  • K012496Carbon PostJ. Morita USA, Inc. · 2002

https://510kreport.com/device/K000311 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000311: Parapost Fiber White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000311

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026